We provide support to agribusiness companies with respect to the rules and policies that affect the sector’s operations. We advise on the development of compliance strategies and on the monitoring of relevant legislation, ensuring that clients operate lawfully and maximize their business opportunities, with a proactive view of regulatory matters.
Work Highlights
We collaborated with a major agribusiness company to develop and implement a robust compliance program, which included the creation of internal policies, training sessions, and monitoring procedures, mitigating legal risks and strengthening the culture of integrity and trust among stakeholders
We proactively monitored federal and state legislative changes for a group engaged in the cultivation and processing of GMOs. We developed detailed analyses and informative reports, enabling the group to adapt quickly to new requirements, avoid penalties, and optimize its operations in a restrictive regulatory environment
We are a specialized team with extensive experience assisting our clients in addressing a wide range of regulatory matters, from domestic challenges to cross-border issues. In a sector that frequently faces significant regulatory burdens, our mission is to support companies through this intricate landscape. We advise on all corporate and commercial operations within the sector. We participate in structuring all projects of interest to this industry. Our regulatory practice also permeates integrity policies and investigative procedures, particularly internal investigations and field actions, as well as interactions between the regulated sector and healthcare professionals. We provide comprehensive advisory services on administrative matters involving regulatory authorities such as ANVISA, MAPA, INMETRO, Professional Councils, and CONAR. We work closely with our Litigation and Arbitration team to resolve any disputes, such as those related to food safety, civil liability, advertising and promotion of regulated products, and contractual disputes. Our advisory scope also covers CBPF, CBPD, AFE, LS, AVCB, RADAR, LI, product regularization and registration, validation and accreditation of manufacturing plants, technovigilance, cultivars, Codex Alimentarius, among others. We are also well positioned to address the regulatory challenges affecting the manufacturing and distribution of nutritional products with medicinal applications and uses. We support digitalization initiatives in the country’s food and beverage consumer market, with significant expertise in cybersecurity, data privacy, and emerging technologies such as generative artificial intelligence and wearable technology. We also constantly monitor political changes and their impact on the sector, including financial regulatory matters, such as anti-money laundering rules (AML/KYC).
Work Highlights
We advised a multinational company in the creation of a new business unit focused on introducing innovative technologies in the food and beverage industry, with an emphasis on nutritional health. Our team assisted the company in navigating the relevant regulations, ensuring that its nutritional tracking solutions were fully compliant with cybersecurity and data privacy guidelines. We successfully optimized the implementation of these innovations while preserving regulatory compliance and consumer trust
We assisted a multinational food company in obtaining all necessary registrations and approvals with ANVISA and the main regulatory authorities, including MAPA, INMETRO, the Federal Revenue Service, the State Treasury Department, the Municipal Authorities, the Fire Department, Professional Councils, and CONAR. This support was crucial for the establishment of a new manufacturing facility and for the regulatory approval of the products associated with a new line of business of the company in the country
We conducted an internal investigation with a large food industry company to assess potential violations of integrity policies. Our efforts helped identify risk areas, resulting in the implementation of a new compliance program that increased transparency and reduced exposure to litigation
We worked alongside a client’s regulatory team in shaping its advertising strategy, in order to substantiate the promotions of a regulated product
We handle regulatory matters for consumer goods and retail with an end-to-end perspective, integrating sector compliance (ANVISA/MAPA/INMETRO), labeling, claims, and advertising (CONAR), consumer protection, and ESG governance. We structure and audit portfolios, registration/notification dossiers, PATE/Good Practices, traceability, and reverse logistics, managing greenwashing and recall risks. We collaborate in the drafting of contracts typical of the sector, such as third-party manufacturing/CMO, private label, co-packing, distribution, consignment, trade marketing/merchandising, and JBP agreements, among others. We model SLAs, commercial policies, promotions, and pricing, with evidence retention and antitrust/anti-bribery controls. In the digital space, we advise e-commerce businesses and marketplaces on terms, returns/chargebacks, payment methods, anti-fraud, dropshipping, and last mile. We handle LGPD matters for CRM and personalization, consent management, and the use of data in campaigns and customer service/ombudsman channels. We conduct defenses before PROCONs/Senacon, health surveillance authorities, and Inmetro. We manage recalls together with the litigation and arbitration team, as well as mandatory notifications. We support import/export, regulatory due diligence, and portfolio M&A. We implement compliance and serialization technologies to reinforce transparency and traceability across the chain.
Work Highlights
We advised a leading manufacturer of industrial tools and household utensils on the creation of a comprehensive recall strategy in more than twenty countries in Latin America and the Caribbean. Our work included the development of robust and tailored policies and contingency plans, the implementation of transparent communication channels to strengthen customer trust, and the optimization of logistics processes and information systems to ensure efficiency. With such support, we helped our client, recognized for its excellence and leadership in the industry, to mitigate risks and protect its reputation, ensuring consumer safety and minimizing the impact of defective products
We advised a renowned Latin American pharmaceutical company, with a prominent presence in the health and wellness sector - especially in the cosmetics and personal care segments - on the restructuring of its operations in Brazil. We carried out an in-depth analysis of the feasibility of a new corporate and logistics-commercial model, with the aim of optimizing its activities and improving its commercial flow. Our work encompassed a complete assessment of the distribution chain, the mapping of strategies for operational efficiency, and regularization before the competent governmental and health authorities, anticipating legal implications and ensuring compliance with local regulations. With this strategic advice, we enabled our client to consolidate its competitiveness, adapt swiftly to the Brazilian market, and ensure strict compliance with the applicable regulatory standards
We provide support in monitoring public consultations and legislative processes, including the Brazilian Emissions Trading System and the regulation of Article 6 of the Paris Agreement, ensuring that our clients are prepared to navigate emerging regulations. We also provide training and literacy services for our clients’ internal teams, preparing them to operate in regulated carbon markets, ensuring strategic alignment with the regulations in force and maximizing market opportunities.
Work Highlights
We advised an association on monitoring the regulatory process of Article 6, ensuring that its interests were considered in international and national developments. This allowed the association to prepare for the requirements of carbon and international credit markets
We analyzed the impact of the European Union’s Carbon Border Adjustment Mechanism (CBAM) for various companies, identifying potential risks and opportunities in their operations and exports. Our focus was to ensure the competitiveness of these companies and compliance with the environmental requirements of the European market
We advised an association on the preparation of a contribution to the public consultation on the certification methodology under VERRA’s VCS program, ensuring that our clients’ interests were represented in the regulatory process and ensuring compliance with the requirements necessary for credit certification
We held specialized workshops for companies from various sectors that may be affected by the Brazilian Emissions Trading System (SBCE). These workshops train the companies’ teams to deal with the emerging regulatory landscape, preparing them for future challenges and identifying opportunities within Brazil’s new regulated carbon market
The National Agency of Petroleum, Natural Gas and Biofuels (ANP) comprehensively regulates all activities in the oil sector, from concessions for exploration and production to the regulation of upstream, midstream, and downstream operations. Oil assets and support structures are also subject to regulation by other Brazilian authorities, such as the Brazilian Navy, the National Agency for Waterway Transportation (ANTAQ), and the National Health Surveillance Agency (ANVISA). Companies must ensure compliance with the regulations in force and deal with the complexity of the licensing and authorization processes required to operate. Failure to comply with regulations may result in sanctions, fines, and the suspension of operations, significantly impacting the business.
Work Highlights
We advise IOCs and NOCs in the negotiation of TACs (Conduct Adjustment Agreements) with the ANP regarding local content investments under concession contracts for oil exploration and production
We advised a NOC in the process of obtaining a reinterpretation of the requirements for posting decommissioning guarantees due to a regulatory gap
We advise IOCs in administrative proceedings for the renegotiation of development plans in order to obtain royalty reductions and an extension of the contractual term
We understand the complexity of the rules governing the sports sector in Brazil. We provide guidance on compliance and regulatory matters, helping clubs, federations and athletes comply with the legislation in force, such as the Pelé Law, the SAF Law and the rules of the Brazilian Football Confederation (CBF). We assist in obtaining the licenses required to organize events and advise on regulations related to sports betting, particularly in the context of the sector’s recent liberalization.
Work Highlights
Advice on general and electoral meetings, as well as on the drafting and review of bylaws for various clients in light of the regulations in force
Representation in administrative disputes, ensuring the defense of our clients’ interests and a form of operation that complies with regulatory requirements
We are a specialized team with extensive experience in helping our clients address a wide range of regulatory issues, from domestic challenges to cross-border matters. In a sector that frequently faces significant regulatory burdens, our mission is to support companies in this intricate landscape. We act in all corporate and commercial transactions in the sector. We take part in the structuring of all projects of interest to health. Our regulatory work also permeates integrity policies and investigative procedures, notably internal investigations and field actions, as well as the interaction between the regulated sector and healthcare professionals. We provide full advice on administrative matters involving regulatory bodies such as ANVISA, MAPA, INMETRO, IPEMs, CFM, CFF, CREFITO, and CONAR, working closely with our Litigation and Arbitration team to resolve any disputes, such as those associated with PBMs, NPPs, safety, quality, efficacy, and the advertising and marketing of regulated products in Brazil. Our advice also covers aspects such as CBPF, CBPD, AFE, AE, LS, AVCB, RADAR, LI, the regularization and registration of health products and solutions, SaMD, pharmacovigilance, technovigilance, plant cultivars, among others. For the exploitation of Brazilian genetic heritage or GMOs, we work closely with our environmental law specialists. We are also well positioned to address the regulatory challenges affecting the manufacture and distribution of biological, biotechnological, and biosimilar products, in both human and animal health. Our expertise extends to non-clinical testing and clinical research, ensuring compliance with the obligations before the Research Ethics Committees. We develop drug pricing strategies (DIP) for interaction with CMED. We support digital health initiatives that include patient data interoperability and RWD processing, cybersecurity, privacy, medtechs, and emerging technologies such as generative artificial intelligence, wearable technology, health gadgets, quantum computing, IoMT, blockchain, big data analytics, etc. We also constantly monitor policy changes and their impact on the sector, including financial regulatory matters such as anti-money laundering rules (AML/KYC).
Work Highlights
We worked closely with a global pharmaceutical company to develop policies ensuring regulatory and ethical compliance in the use of its generative artificial intelligence in healthcare. In addition, we provided strategic guidance on the implementation and ongoing monitoring of these policies, with the aim of promoting transparency, safety, and effectiveness in the application of AI across the company's operations, especially in research and development processes. We prepared documents designed to maximize the benefits of AI technology while mitigating potential risks and ensuring the responsible and ethical use of the data and algorithms involved
We provided regulatory legal advice to a leading medical technology and digital health company operating in a highly regulated environment. Our role was to ensure that the company complied with all applicable rules and regulations while seeking to innovate and expand its presence in the healthcare market. In addition, we assisted in forming strategic partnerships and collaborations with other industry players, driving this medtech company's expansion initiatives in the Latin American market
We advised a leading European pharmaceutical company specializing in medicines for rare diseases. We developed strategies to facilitate market entry and optimize reimbursement processes, identifying promising partnerships and early access initiatives that expanded the availability of treatments to patients. We supported the company in its decisions on corporate structure and strategic partnerships, strengthening its presence and competitiveness in the Brazilian market
We support agribusiness companies with respect to the rules and policies that affect the sector's operations. We advise on developing compliance strategies and on monitoring relevant legislation, ensuring that clients operate lawfully and maximize their business opportunities, with a proactive view of regulatory matters.
Work Highlights
We worked with a large agribusiness company to develop and implement a robust compliance program, which included creating internal rules, training, and monitoring procedures, mitigating legal risks and strengthening the culture of integrity and the trust among stakeholders
We proactively monitored legislative changes at the federal and state levels for a group engaged in growing and processing GMOs. We prepared detailed analyses and informative reports, enabling the group to adapt quickly to new requirements, avoid penalties, and optimize its operations in a restrictive regulatory environment
The National Mining Agency (Agência Nacional de Mineração – ANM) broadly regulates the activities of the mining sector, from the granting of mining rights to the regulation of extraction and processing operations. In addition, mining companies are subject to regulation by other Brazilian authorities, such as IBAMA and state agencies. Compliance with the regulatory rules in force is essential for the continuity of operations, and non-compliance may result in severe sanctions, including fines and suspension of activities.
Work Highlights
We advised mining companies in administrative proceedings before the ANM to maintain the validity of mining rights and in disputes over title to those rights
We have expertise across the full range of regulatory matters related to the maritime industry, including the import, operation, construction, chartering, flagging and recycling of vessels, subsea construction, marine insurance, ship-to-ship and ship-to-barge operations, as well as interface with regulatory agencies and competent authorities, such as the Agência Nacional do Petróleo, Gás Natural e Biocombustíveis (ANP), the Agência Nacional de Transportes Aquaviários (ANTAQ), the Agência Nacional de Vigilância Sanitária (ANVISA) and the Brazilian Maritime Authority (Marinha do Brasil). Our experience also includes advising on obtaining authorizations to operate in Brazil, the operation of Empresas Brasileiras de Navegação (EBNs), regulation for cabotage, offshore support, port support and long-haul shipping, the structuring of projects in compliance with the applicable regulations, and the development, construction, licensing and operation of port facilities such as private use terminals (TUPs) and public ports, waterway transport support facilities and other port facilities.
Work Highlights
We advised a Turkish shipowner on the maritime and port regulatory framework for the deployment of a power-generating vessel (powership) in Brazil in an emergency public tender, to supply power amid an energy crisis in the country
We advised an Australian exploration and production company in negotiations and on regulatory and tax matters related to the assignment and amendment of the FPSO contracts, following an M&A transaction in which the firm advised the client on the acquisition of the field's exploration rights from Petrobras
We advised several international shipowners in the process of setting up their shipping companies in Brazil, including on the acquisition and/or chartering of their first Brazilian vessels and on obtaining the ANTAQ authorization to operate as an EBN. We recently advised one of the largest offshore construction groups in a similar process, enabling the expansion of its operations in Brazil with the use of HLV and PLSV type vessels and other highly specified vessels
We offer effective policy and compliance solutions and identify regulatory strategies to mitigate regulatory risks, aiming to maintain competitiveness and align the client's business with changes in the technology sector. Our work includes specialized legal support focused on the impact of disruptive technologies, such as artificial intelligence (AI), generative artificial intelligence (Gen AI), wearable devices, the internet of things (IoT), the internet of medical things (IoMT), quantum computing, gadgets, augmented reality (AR) and virtual reality (VR). Our goal is to ensure that the development and implementation of these innovations comply with the applicable regulations, at the national and/or international level, combining legal expertise and technical knowledge to help the client navigate the regulatory landscape and identify strategic technological solutions for the business, safely and efficiently.
Work Highlights
We advised one of the world's largest financial market infrastructure companies, active in both exchange and over-the-counter environments, on a commercial partnership aimed at launching a carbon credit trading platform in Brazil
We advised one of the world's largest pharmaceutical companies on the development and implementation of two internal tools based on artificial intelligence, designed to optimize work processes and assist in generating insights and reports, in order to support, for example, research and development and to facilitate strategic decision-making. Our work included creating and adapting legal mechanisms to ensure full compliance with local legislation, with a focus on intellectual property rights, data protection and industry best practices. We reviewed the platforms' manuals and guidelines, ensuring that the combination of generative artificial intelligence with productivity solutions delivered an integrated, secure and efficient experience. This approach was designed to be applicable in various jurisdictions around the world, allowing the company to operate effectively and in accordance with local regulations
We advised a leading player in the pharmaceutical sector on assessing the risks associated with the use of artificial intelligence to create videos with extremely realistic avatars, both based on real people (real-person avatars) and entirely generated by AI (AI-generated avatars). Our work involved a detailed analysis of the regulatory and intellectual property risks related to the implementation of this technology in Brazil, identifying potential legal challenges and ensuring compliance with the legislation in force. In addition, we developed recommendations for the adoption of risk mitigation measures, ensuring that the company could explore the opportunities offered by this innovation safely and responsibly
